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In patients with locally advanced or metastatic tumors, first-line therapeutic management is based on the use of targeted therapies (EGFR, BRAF ALK and ROS1 inhibitors), immunotherapies (anti-PD1/ anti-PDL1-antibodies or chemotherapy.
Despite patient selection based on histo-pathological and molecular criteria, not all patients respond to treatment. There are currently no markers to definitively guarantee a patient's response.
An alternative is to identify early patient response to treatment. The investigator hypothesize that change in circulating tumor DNA concentration (ctDNA) allow to early identify patients' therapeutic response (and non-response) of patients, regardless of the type of treatment used in the first line setting.
The primary objective is to determine whether early evolution (between baseline and week 3) of circulating tumor DNA concentration predicts the radiological response to first-line treatment of advanced or metastatic NSCLC patients, regardless of treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ctDNA analysis | Experimental | additional blood sample of 20 ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ctDNA analysis | Other | blood sample at Baseline, 3weeks, 9 weeks after treatment, at progression if applicable |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biological response at week 3 | Changes of the amount of ctDNA between baseline and week 3 will make it possible to determine the biological response: increase, stability or decrease in ctDNA. | week 3 after patient's recruitment date (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (radiological assessment) and biological response at week 3. | Radiological assessment, based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1, will be: complete response, partial response, progression or stabilization. Biological response will be: increase, stability or decrease in ctDNA. | week 3 after baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc DENIS | CHD Vendee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marie MARCQ | La Roche-sur-Yon | 85000 | France | |||
| Jaafar BENNOUNA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40075630 | Background | Herbreteau G, Marcq M, Sauzay C, Carpentier M, Pierre-Noel E, Pons-Tostivint E, Vallee A, Theoleyre S, Bizieux A, Bennouna J, Denis MG. Absolute Quantification of Nucleotide Variants in Cell-Free DNA via Quantitative NGS: Clinical Application in Non-Small Cell Lung Cancer Patients. Cancers (Basel). 2025 Feb 25;17(5):783. doi: 10.3390/cancers17050783. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| biological progression and radiological progression | Biological progression will be: increase in ctDNA - Radiological progression will be defined according to RECIST criteria v1.1 will be: progression | progression |
| biological response and radiological response | Biological response will be: increase, stability or decrease in ctDNA and Radiological response will be defined according to RECIST criteria v1.1 will be: complete or partial response | progression |
| Biological response and progression-free survival (radiological assessment) according to the therapeutic management: targeted therapies, immunotherapy, chemotherapy | Radiological assessment, based on RECIST criteria v1.1, will be: complete response or partial response. Biological response will be: increase, stability or decrease in ctDNA. | week 3 after baseline |
| Nantes |
| 44000 |
| France |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |